健康成人を対象とした第１相試験におけるＲａｐｉｄ　ＡＣＴＨ　Ｔｅｓｔの評価基準の検討

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  • Normal Range of Rapid ACTH Test for Healthy Subjects in Phase I Studies.

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The rapid ACTH test is used to evaluate adrenocortical function in healthy subjects in phase I studies. Several criteria have previously been reported for patients. However, each of the evaluations are not necessarily applicable for healthy subjects.<BR>The purpose of this study was to determine which criterion is the most suitable for healthy subjects in phase I studies. We enrolled 244 healthy male subjects, aged 20-39, who gave written informed consent before entering the study. They underwent the standard rapid ACTH test, consisting of measurement of plasma cortisol levels before and at 30 and 60 minutes after intravenous injection of 0.25 mg tetracosactide acetate (Cortrosyn ®). Cortisol levels were measured by GammaCoat antibody-coated tube radioimmunoassay.<BR>When the adrenocortical function of healthy subjects was evaluated by the criteria of the increment (peak level minus initial cortisol level) or the ratio (peak level/initial level), unreasonable results were obtained in that those with a higher initial cortisol level, tended to fall outside of some of the criteria. Therefore these criteria do not seem suitable for healthy subjects in phase I studies. We consider that the criterion of the peak cortisol level is more applicable than the criteria, because at least it did not give unreasonable results. The findings suggest that a peak cortisol level of greater than or equal to 20μg/dl, as evaluated by the rapid ACTH test, is a sufficient criterion for healthy subjects in phase I studies.

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  • 臨床薬理

    臨床薬理 31 (4), 557-563, 2000

    一般社団法人 日本臨床薬理学会

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